Label: JACK BLACK CLEARING SPOT TREATMENT- sulfur gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 3, 2022

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  • Active Ingredients

    Sulfur 10%

    Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Dries and clears acne blemishes and blackheads and allows skin to heal.
  • Warnings

      For external use only

    When using this product

    • apply only to areas with acne
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical medication at a time.
    • avoid product contact with silver jewelry.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away

    Do Not Use

    • On broken skin
    • on large areas of the skin
  • Directions

    • Clean the skin thoroughtly before applying this product
    • cover the entire ara with a thin layer one to three times daily
    • Because excess drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Glycerin, Caprylic/Capric Triglyceride, Acacia Senegal Gum, Magnesium Aluminum Silicate, Glyceryl Stearate,
    PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Butylene Glycol, Decylene Glycol, Zinc PCA, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Sodium PCA, Isohexadecane, Ganoderma Lucidum Extract, Sodium Hydroxide, Bisabolol, Ethylhexylglycerin, Polysorbate 80, Lysine, Propanediol, Aloe Barbadensis Leaf Juice, Tetrasodium Glutamate Diacetate, Curcuma Longa (Turmeric) Root Extract, Camellia Sinensis Leaf Extract, 10-Hydroxydecanoic Acid, Sebacic Acid, Magnesium Chloride, Potassium Chloride,
    Sodium Chloride, 1,10-Decanediol, Zinc Chloride

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    JACK BLACK CLEARING SPOT TREATMENT 
    sulfur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66738-436
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ALOE (UNII: V5VD430YW9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    GANODERMA LUCIDUM WHOLE (UNII: J5P04QW0CF)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LYSINE (UNII: K3Z4F929H6)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
    SEBACIC ACID (UNII: 97AN39ICTC)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    1,10-DECANEDIOL (UNII: 5I577UDK52)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66738-436-011 in 1 CARTON02/12/2021
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00602/12/2021
    Labeler - Jack Black LLC (847024036)
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